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Long-term Paired Associative Stimulation as a Treatment for Incomplete Spinal Cord Injury of Non-traumatic Origin

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ClinicalTrials.gov Identifier: NCT03104803
Recruitment Status : Enrolling by invitation
First Posted : April 7, 2017
Last Update Posted : August 9, 2017
Sponsor:
Collaborators:
Validia Rehabilitation Center
Helsinki University
Information provided by (Responsible Party):
Anastasia Shulga, Helsinki University Central Hospital

Brief Summary:
The investigators have recently shown in incomplete SCI patients that long-term paired associative stimulation is capable of restoring voluntary control over some paralyzed muscles and enhancing motor output in the weak muscles (1). In this study, the investigators will administer long-term paired associative stimulation to patients with incomplete SCI of non-traumatic origin.

Condition or disease Intervention/treatment Phase
Spinal Cord Diseases Spinal Cord Injuries Device: long-term paired associative stimulation Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Long-term Paired Associative Stimulation as a Treatment for Incomplete Spinal Cord Injury of Non-traumatic Origin
Actual Study Start Date : March 31, 2017
Estimated Primary Completion Date : April 4, 2018
Estimated Study Completion Date : June 4, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Long-term PAS
The intervention is given to one hand only
Device: long-term paired associative stimulation
Paired associative stimulation (PAS) administered several times per week for 6 weeks to one hand. PAS comprises transcranial magnetic stimulation (eXimia magnetic stimulator, Nexstim Ltd, Helsinki, Finland) and peripheral nerve stimulation (given with Dantec Keypoint® electroneuromyography device (Natus Medical Incorporated, Pleasanton, CA, USA)).

No Intervention: No intervention
Contralateral hand of the same patient



Primary Outcome Measures :
  1. Daniels and Worthingham's Muscle Testing [ Time Frame: 2 days after the last stimulation session ]
    each hand muscle is evaluated on 0-5 scale

  2. Daniels and Worthingham's Muscle Testing [ Time Frame: 1 month after the last stimulation session ]
    each hand muscle is evaluated on 0-5 scale



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • incomplete SCI of non-traumatic origin

Exclusion Criteria:

  • epilepsy
  • metal inclusion in the head area
  • pacemaker
  • hearing device
  • high intracranial pressure

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03104803


Locations
Finland
BioMag laboratory
Helsinki, Finland
Sponsors and Collaborators
Helsinki University Central Hospital
Validia Rehabilitation Center
Helsinki University

Publications:
Responsible Party: Anastasia Shulga, MD, PhD, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT03104803     History of Changes
Other Study ID Numbers: ULD 8100014-2
First Posted: April 7, 2017    Key Record Dates
Last Update Posted: August 9, 2017
Last Verified: August 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System